Diabetic Ketoacidosis: Brain Morphology and Cognition

Overview

The purpose of this study is to assess brain and memory changes in patients with uncontrolled diabetes (a condition called diabetic ketoacidosis (DKA))

Full Title of Study: “Acute and Long-term Neuroanatomical and Cognitive Evaluation of Adult Patients With First and Recurrent Episodes of Diabetic Ketoacidosis”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 25, 2016

Detailed Description

Diabetic ketoacidosis (DKA) is a common and serious medical problem. Most cases occur when patients forget or stop insulin injections. Some patients require frequent admissions to the hospital with DKA after stopping insulin. Many patients do not know why they stop insulin therapy. The investigators will test if patients with one or more episodes of DKA have poor memory and brain changes that may lead to poor management. In this study, the investigators will perform memory testing and brain images in subjects with initial DKA episode and subjects with more than 3 episodes of DKA. The results will be compared to subjects with diabetes and no history of DKA and healthy (non-diabetic) subjects. Each subject with DKA will have an MRI and cognitive testing done shortly after hospital discharge, 1 month, and 3 months after hospital discharge. Diabetic subjects without DKA and healthy controls will only come in for a single baseline visit and have a MRI and cognitive testing done.

Arms, Groups and Cohorts

  • Healthy Controls
    • Non-diabetic subjects
  • Diabetics without DKA
    • Diabetic subjects (recent(< 1 year) diagnosis of diabetes) without a history of diabetic ketoacidosis (DKA)
  • First episode of DKA
    • Diabetic subjects that just had their primary event of diabetic ketoacidosis (DKA)
  • Three or more DKA episodes
    • Diabetic subjects who have had three or more diabetic ketoacidosis (DKA) episodes

Clinical Trial Outcome Measures

Primary Measures

  • Acute change in brain morphology
    • Time Frame: Baseline, 1 month
    • Changes in brain morphology will include quantitative measurements of regional cortical volume as well as of hippocampal and thalamic volumes. Change is the difference from baseline MRI and 1 month MRI.

Secondary Measures

  • Long-term change in brain morphology
    • Time Frame: Baseline, 4 months
    • Changes in brain morphology will include quantitative measurements of regional cortical volume as well as of hippocampal and thalamic volumes. Change is the difference from baseline MRI and 4 month MRI.
  • Change in neurocognitive assessment
    • Time Frame: Baseline (72 hours after DKA), 3 months
    • Assessment will focus in composite domains: verbal memory, visual memory, working memory, prospective memory, executive function processing speed, and reaction time. Change is the difference from baseline assessment and 3 month assessment.
  • Change in neurocognitive assessment
    • Time Frame: Baseline (72 hours after DKA), 6 months
    • Assessment will focus in composite domains: verbal memory, visual memory, working memory, prospective memory, executive function processing speed, and reaction time. Change is the difference from baseline assessment and 6 month assessment.

Participating in This Clinical Trial

Inclusion Criteria

  • Type 1 or type 2 diabetes with diabetic ketoacidosis (DKA) – Age 18-50 years – Newly diagnosed or history of noncompliance with insulin therapy as precipitating cause of DKA – No significant medical or surgical illness as precipitating cause of DKA Exclusion Criteria:

  • Significant medical/surgical illness as precipitating cause of DKA (i.e. myocardial infarction, major surgery) – Associated significant medical or surgical condition within 6 months history – History of hypoglycemia unawareness – History of seizures, ischemic stroke or hemorrhage, and severe head trauma – History of symptomatic stenosis of major intracranial vessels – Dementia (mini-mental state examination (MMSE) score (r ≤ 24) or inability to cooperate) – Liver or renal failure or transplant – Severe hypertension (systolic blood pressure (BP) >160 mm Hg and/or diastolic BP >100 mm Hg or subjects taking ≥ 2 antihypertensive medications) – Malignancy – Current recreational drug or alcohol abuse – Magnetic resonance imaging (MRI) exclusions: any metal and bio-implants not compatible with 3 Tesla MRI, claustrophobia

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Emory University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Guillermo Umpierrez, Professor – Emory University
  • Overall Official(s)
    • Guillermo Umpierrez, MD, Principal Investigator, Emory University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.